FDA.reportPublic FDA data

Pediatric Body Array

Primary DI
00860008041326
Brand
Pediatric Body Array
Company
Inkspace Imaging, Inc.
Model
PBA24GE30A
Device description
The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution pediatric body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Pediatric Body Array were designed specifically to fit the pediatric population for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient’s anatomy.
Published
2022-02-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213397000InkSpace Imaging Pediatric Body ArrayInkspace Imaging, Inc.2021-12-17MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008041326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008041326008600080413268600080413260860008041326

GMDN Terms#

Term, Definition table
TermDefinition
MRI system coil, radio-frequencyA radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
925-425-7411my.nguyen@inkspaceimaging.com

Regulatory Flags#

DUNS number
080330758
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083516000Nuzzle Body Array, 1.5TSBA24SH15D2026-04-21
00850083516017Silhouette Body Array – PH 3T (Cherry Blossoms)SBA12PH30B2026-04-21
00860008041371Snuggle Pediatric Array – PH 3T (Dino)SBA12PH30A2026-04-21
00860008041395Nuzzle Body Array – PH 3T (Whimsical)SBA12PH30C2026-04-21
00860008041364Snuggle Pediatric Array, 1.5TSBA24SH15B2026-01-22
00860008041388Silhouette Body Array, 1.5TSBA24SH15C2026-01-22
00860008041333Snuggle Pediatric ArraySBA24GE30A2024-11-25
00860008041357Nuzzle Veterinary ArraySBA24SH30D2024-11-25
00860008041302Snuggle Pediatric ArraySBA24SH30B2024-02-08
00860008041319Silhouette Adult ArraySBA24SH30C2024-02-08
00860008041340InkSpace Imaging Body ArrayPBA24GE30B2023-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278925282NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDMOS2026-05-11
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
00814848020836Contour Hand Wrist 0.55TQUALITY ELECTRODYNAMICS LLCMOS2026-04-23
00850083516000Nuzzle Body Array, 1.5TInkspace Imaging, Inc.MOS2026-04-21
00850083516017Silhouette Body Array – PH 3T (Cherry Blossoms)Inkspace Imaging, Inc.MOS2026-04-21
00860008041371Snuggle Pediatric Array – PH 3T (Dino)Inkspace Imaging, Inc.MOS2026-04-21
00860008041395Nuzzle Body Array – PH 3T (Whimsical)Inkspace Imaging, Inc.MOS2026-04-21
00884838130548DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130555DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130562DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130579DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130586DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130593DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130609DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130616DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130623DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132597DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132603DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
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00884838098190MRI CoilsPhilips Ds North America LLCMOS2025-10-01
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00884838098510MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838108073MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838118997MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-10-01
00884838119000MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-10-01
00884838108080MRI CoilsPhilips Ds North America LLCMOS2025-09-30
00884838111172DUNLEEPhilips Medical Systems Nederland B.V.MOS2025-09-30